Arrow Central Venous Catheter Kits Recalled for Unsealed Packaging
Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential sterility compromise due to packaging issues without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Pressure Injectable Multi-Lumen Central Venous Catheterization Kits with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions (Product Code: ASK-42703-PHCH). The recall is due to unsealed packaging, which may compromise the sterility of the product.
The affected products were distributed in the United States and internationally, including Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, the Netherlands, New Zealand, Panama, the Philippines, Poland, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, and the United Kingdom. The specific lot numbers involved are 13F17B0408, 13F17E0421, and 13F17L0288.
Healthcare facilities and consumers should stop using these products and contact Arrow International Inc for further instructions or a refund.
The recalled product
- Product
- Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-PHCH
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 416,055
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 13F17B0408 13F17E0421 13F17L0288
Distribution
Part of a larger recall action
This product is one of 76 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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